WILLEM AI ECG registry for adults at high risk of heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a large, single-group observational registry that will collect both retrospective and prospective ECGs and linked clinical data to generate real-world evidence on WILLEM's performance. The platform will process raw ECG tracings from a range of devices (12-lead, Holters, wearables, patches, telemetry, etc.) that meet minimum duration and sampling requirements. Sites will submit de-identified ECG raw data and associated clinical information so WILLEM's automated interpretations can be compared with clinical findings and local standards of care. The study focuses on adults admitted to cardiovascular units who are considered high risk for cardiac disease across participating hospitals in the US and Spain.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* EC/IRB approval of ICF waiver prior to recruitment; otherwise, signed informed consent form by subject and investigator
* Age \> 18 years-old, with no upper limit
* Subjects undergoing standard of care electrocardiogram (ECG) of any duration from any hardware device
* All available, but at least one, legible ECG tracings in raw data format (e.g. DICOM, XML, EDF, JSON, HL7, SCP, WFDB, CSV, etc.)
* Available subject clinical data associated with the ECG
* For 12-lead ECGs, a minimum length of 10 seconds at a minimum sample frequency of 250 Hz
* For ECGs from Holters, wearables, patches, insertable cardiac monitors, telemetries, etc., a minimum length of 30 seconds at a minimum sample frequency of 200 Hz with a lead I / II or its MCL-DII lead approximation
* For prospective eligibility only:
* Signed informed consent form, unless previously waived by the EC/IRB
* Site technical viability for ECG and subject clinical data transfer (e.g. end-to-end integration following interoperability standards such as FHIR, HL7 or DICOM)

Exclusion Criteria:

* Unavailable or suboptimal quality of the raw data from the ECG signal
* Age \< 18 years-old

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting
• CardioHeredia
  Guayaquil, Guayas, Ecuador Recruiting
• Puerta de Hierro University Hospital
  Madrid, Spain Recruiting
• La Paz University Hospital
  Madrid, Spain Not yet recruiting
• Murcia University
  Murcia, Spain Not yet recruiting

Study contacts

• Study coordinator: Manuel Marina-Breysse, MD, PhD
• Email: clinical@idoven.ai
• Phone: +34669752391

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.